Senior Scientist, Quality Control Lts

The Scientist, Laboratory Technical Services is primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of physical and chemical analyses (including the most complex analyses) using all equipment. This position will have a significant role supporting pending ANDA submissions, product launches, and method lifecycle activities to achieve company goals and initiatives. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Chemists.

All incumbents are responsible for following applicable Division & Company policies and procedures.

KEY ACCOUNTABILITIES

Analysis & Testing

• Validates analytical methods for Finished Product and Raw Material release and stability testing
• Evaluates, troubleshoots/improves existing analytical methods when necessary
• Prepares method validation protocols, reports, and analytical test methods
• Performs testing to support process and formulation development (e.g. excipient compatibility, solubility, dissolution studies, stability/impurity assessment)
• Performs work to support project as assigned with little oversight
• Presents analytical data to project team for review and discussion
• Reviews and approves laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test method, validation protocol, or validation report) for completeness and compliance when necessary
• Reviews and evaluates drug substance supplier’s technical documents to ensure internal test requirements are adequate
• Uses laboratory software for analyses
• Is alert to and detects abnormalities during performances of tests and reviews

Lab Equipment

• Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
• Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
• Troubleshoots instrumentation and performs subsequent analyses

Investigations

• Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action related to LTS activities
• Participates in root cause identification of complex laboratory investigations
• Writes, edits, and reviews SOPs and laboratory investigations

Training

• Trains junior Scientists/Chemists on analytical techniques
• Continuously updates knowledge with respect to the latest technologies related to analytical science
• Maintains assigned training records current and in-compliance
• Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures

Compliance

• Identifies need for SOPs and writes or revises, as appropriate
• Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations
• Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs
• Takes active role in auditing laboratory logbooks/documentation to ensure compliance
• Follows internal processes related to controlled substances

Safety

• Follows EH&S procedures to ensure a safe work environment
• Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS

QUALIFICATIONS

Education & Experience

• Bachelor of Science Degree in chemistry, chemical engineering or related field with 6 years’ relevant analytical laboratory experience OR
• Master’s Degree in above disciplines with 4 years’ relevant analytical lab experience OR
• PhD in above disciplines with some relevant analytical laboratory experience preferred

Knowledge

• Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports
• Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
• Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS
• Has demonstrated competence in conducting chemical analyses
• Strong knowledge of wet chemistry techniques